HPV Vaccine Found Safe in Large Study

MONDAY, Oct. 1 (HealthDay News) -- The most common side effects in girls and young women who receive the human papillomavirus (HPV) vaccine appear to be fainting right after the injection and skin infections where the shot was given, a new study confirms.

The quadrivalent (HPV4) vaccine -- brand name Gardasil -- is given to girls aged 9 and up to protect them from cervical and other cancers caused by the virus. It has been used in the United States for six years.

"We did not detect any new safety concerns with this vaccine," said lead researcher Dr. Nicola Klein, of the Kaiser Permanente Vaccine Study Center in Oakland, Calif.

She noted that the team looked at many different possible side effects. "This is a very reassuring finding," she added.

Fainting on the same day as vaccination has been associated with other injections as well as Gardasil -- particularly among adolescents -- and skin infection is a concern with any injection, Klein said.

The report was published in the Oct. 1 online edition of the Archives of Pediatrics & Adolescent Medicine.

The study, funded by Merck & Co., the maker of the vaccine, was required by the U.S. Food and Drug Administration to determine which immediate side effects resulted from the vaccine.

Study participants were females aged 9 to 26 who received at least one of the three recommended doses of Gardasil between August 2006 and March 2008.

Among nearly 190,000 girls or young women vaccinated, only fainting on the day of vaccination and skin infections within the next two weeks were deemed likely to be associated with the vaccine.

"These findings support the general safety of routine vaccination with HPV4 to prevent cancer," the researchers said.

Although some of these skin infections may have been a local reaction where the injection was given, more girls sought care for a skin infection a while after the vaccination, the researchers noted.

HPV viruses are common types of sexually transmitted viruses. Although most cause no symptoms and go away on their own, genital HPV infection can cause cervical cancer, as well as other cancers and genital warts in both women and men. In June 2006, the FDA approved the HPV vaccine for girls and women aged 9 to 26, according to study background information, which noted that approval has since been expanded for males in that age group.

"This substantiates the belief we had about the HPV vaccine -- that it's a safe vaccine," said Dr. Elizabeth Poynor, a gynecologic oncologist and pelvic surgeon at Lenox Hill Hospital in New York City. Poynor was not involved with the study.

Poynor agreed fainting is not uncommon with other vaccines. "This is a potential side effect of any type of vaccination," she said.

Real-world experience with drugs and medical devices often differs from what was found in clinical trials, but now the safety of the HPV vaccine has been substantiated with real-world data, Poynor said.